The Prescription Drug Retail Price List rules, N.J.A.C. 13:39-5.13 and 13:45A-30.1, were originally proposed by the Division of Consumer Affairs (the Division) and the Board of Pharmacy (the Board) on August 20, 2007 at 39 N.J.R. 3481(a). The rules were proposed in order to implement the provisions of the New Jersey Prescription Drug Price Registry Act, N.J.S.A. 45:14-81, which was signed into law on August 21, 2006. The Act, which became effective on September 1, 2007, requires the Division to create a registry where consumers can readily access and compare the retail prices charged by pharmacies for the 150 most frequently prescribed drugs in the State. The Act also requires pharmacies to maintain a list of the retail prices charged by the pharmacy for each drug on the Division's list and to make this list available to consumers. In the fall of 2007, the Division introduced its prescription drug price registry in electronic format on the Division's website.

A number of comments were received in response to the notice of proposal and several changes have been made in this notice of reproposal to address these comments. A technical change has been made to update the codification of N.J.A.C. 13:45A-30 as 13:45A-32, due to the adoption of two new subchapters by the Division of Consumer Affairs after the original notice of proposal expired pursuant to N.J.A.C. 1:30-6.2(c). Therefore, all references to N.J.A.C. 13:45A-30 in the comments summarized below are responded to by the Division and the Board using N.J.A.C. 13:45A-32, to prevent any confusion.

Public comments to the original notice of proposal were received from the following:

1. COMMENT: One commenter requested that long-term care pharmacies be exempted from the requirements of proposed new rules N.J.A.C. 13:39-5.13 and 13:45A-30.1. The commenter noted that although long-term care pharmacies are licensed as retail pharmacies, long-term care pharmacies serve people with special needs in institutional settings, such as nursing homes and assisted living facilities. Long-term care pharmacies are organized to dispense medications solely to these types of facilities for use by the facilities' residents. The commenter believes that including long-term care pharmacies on the prescription drug price registry will be confusing for members of the general public by leading them to believe that they may have prescriptions filled at one of these pharmacies. One commenter suggested that the Division include a disclaimer on its prescription drug price registry website, advising consumers that long-term care pharmacies are not open to the general public.

RESPONSE: The Division agrees that the inclusion of long-term care pharmacies on the prescription drug price registry may lead to confusion among consumers because such pharmacies do not fill prescriptions for walk-in patients. However, at this time, long-term care pharmacies are licensed as retail pharmacies and, under the Act, cannot be excluded from the prescription drug price registry. No mechanism exists to identify a pharmacy as a long-term care pharmacy in the data provided to the Division by the Division of Medical Assistance and Health Services in the Department of Human Services. The Division, however, will add a disclaimer to the prescription drug price registry website, as suggested by the commenter, advising consumers that some of the pharmacies that appear on the prescription drug price registry are long-term care pharmacies that do not fill prescriptions for members of the general public. The disclaimer will advise consumers to call a pharmacy on the list in order to verify that the pharmacy does, in fact, fill prescriptions for members of the general public.

2. COMMENT: Two commenters believe that the prescription drug price registry is a great resource for consumers because it will provide consumers with essential and accurate drug pricing information. The commenters noted that the prescription drug price registry makes cost comparisons of prescription drugs easy, allowing consumers to realize significant savings.

RESPONSE: The Division agrees that the prescription drug price registry is a useful resource for consumers and thanks the commenters for their support.

3. COMMENT: Two commenters suggested that the prescription drug price registry be reconfigured to permit prescription drug price information to be searchable and printable by a specific pharmacy and by a specific drug, so that both consumers and individual pharmacies may take full advantage of the information on the registry.

RESPONSE: The New Jersey Prescription Drug Price Registry Act requires the Division to create a registry to enable consumers to obtain and compare the retail prices charged by pharmacies for the 150 most frequently prescribed drugs in the State. The intent of the Act and the goal of the registry are to allow consumers to find the lowest price for a particular prescription drug in the consumers' geographic area. The Division believes that the registry, in its current configuration, complies with the requirements of the Act. It permits consumers to search for, view and print relevant prescription drug price information in a manner that is user-friendly. The Division, therefore, declines to alter the prescription drug price registry as suggested by the commenters.

4. COMMENT: One commenter suggested that a "help line" telephone number be posted on the Division's drug price registry website in order to allow pharmacies to report errors in the pricing information that appears on the prescription drug price registry.

RESPONSE: Pharmacies should report any errors in drug price information to the Division of Medical Assistance and Health Services in the Department of Human Services, which supplies the Division of Consumer Affairs with the drug pricing data for the prescription drug price registry. The Division notes that pharmacies should endeavor to [page=1328] ensure that the prescription drug price information reported to the Division on Medical Assistance and Health Services is as accurate as possible, in order to avoid confusion for both pharmacies and the consumers who uses the prescription drug price registry.

5. COMMENT: Two commenters suggested that a disclaimer be added to the prescription drug price registry advising consumers that the prescription drug prices contained in the registry reflect the prices charged to cash paying consumers and that the registry's prices do not reflect the prices that will be charged to consumers purchasing drugs under the Medicare Part D Program or under any private insurance plan that has coverage limits. The commenters believe that such a disclaimer will eliminate potential consumer confusion.

RESPONSE: The Division agrees with the commenters' suggestion and will update the prescription drug price registry website to include a disclaimer advising consumers that the registry's drug prices reflect the usual and customary price for medications where there is no third-party payor involved in the prescription transaction.

6. COMMENT: One commenter objected to the requirement in proposed new rule N.J.A.C. 13:45A-30.1 that a pharmacy's prescription drug price list include the cost for a particular drug in quantities of 30, 60 and 90. The commenter noted that this requirement creates a complex and confusing drug price list that is difficult for consumers to navigate and understand. One commenter noted that requiring the list to contain prices for multiple dosages for a single drug exceeds the intent of the New Jersey Prescription Drug Price Registry Act. Two commenters objected to the inclusion of the price per unit on the prescription drug price list because they believe the price per unit is of limited value to the consuming public. One commenter, however, noted that the price per unit and the cost breakdown for different quantities of the same drug is helpful to consumers because it provides clear and easy to understand price information. One commenter suggested that the Division require a pharmacy's prescription drug price list to include the first, second and third most common dosage of each of the 150 most frequently prescribed drugs on the list. Two commenters suggested that the Division require a pharmacy's drug price list to reflect the cost of the most commonly prescribed dosage for each of the 150 most frequently prescribed drugs on the list in order to make the pharmacy's list more manageable and user-friendly for consumers.

RESPONSE: The prescription drug price list originally provided by the Division to pharmacies throughout the State included numerous dosages for each of the 150 most frequently prescribed drugs in the State. N.J.A.C. 13:45A-32.1(a), as originally proposed, required pharmacies to include on the their drug price list the 150 most frequently prescribed drugs, at their various dosages, the drug's cost per unit, and the cost of each drug for quantities of 30, 60 and 90 units.

After initial dissemination of the list to pharmacies in 2007, the Division was made aware of concerns within the pharmacy community that the maintenance of pricing information for the numerous dosages of each drug on the list, in various quantities, had resulted in an unmanageably large list that was not user-friendly. The Division notes that providing consumers with pricing information for the different dosages of a single drug, as well as the prices for various quantities of a particular drug, is entirely consistent with the intent of the New Jersey Prescription Drug Price Registry Act. Such information permits consumers to more easily make meaningful drug cost comparisons. Because of the registry's various search features, the drug pricing information available on the website can be viewed by consumers in a more manageable format. The Division notes that drug price information for different dosages for each of the 150 most frequently prescribed drugs, the unit price per drug and the cost of the drugs in various quantities, is currently available, and will continue to be available, on the Division's electronic prescription drug price registry. However, the Division agrees with the commenters that requiring a pharmacy to maintain a drug price list with the variations required pursuant to N.J.A.C. 13:45A-32.1(a), as originally proposed, is overly burdensome for pharmacies and confusing for consumers who attempt to search a pharmacy's drug price list while in the pharmacy. Therefore, N.J.A.C. 13:45A-32.1(a), as reproposed, will require a pharmacy to maintain a prescription drug price list that contains the retail price charged by the pharmacy for the 150 most frequently prescribed drugs in the State at the drug's most commonly prescribed dosage, in quantities of 30, 60 and 90 units, if applicable. The pharmacy's prescription drug price list must still include the drug's price per unit because the Division continues to believe that the price per unit will provide consumers with meaningful information for price comparison purposes.

7. COMMENT: Two commenters recommended that the Division amend N.J.A.C. 13:45A-30.1(e), which, as originally proposed, requires a pharmacy to post a sign conspicuously notifying consumers of the availability of the pharmacy's prescription drug price list, to require the Division to prepare the sign and make it available on the Division's website for pharmacies to download and post. The commenters believe that Division-prepared language will help to ensure a uniform notification standard. One commenter recommended that the sign refer to the Division's website and the Division's toll-free telephone number for prescription drug pricing information. The commenter also recommended that the Division require the sign to be in large print and that it be made available in Spanish.

RESPONSE: The Division agrees that a uniform sign should be used to notify consumers about the availability of a pharmacy's prescription drug price list. Moreover, the Division believes that uniform language should be used by pharmacies with respect to price comparison information for generic prescription drugs, as well as the advisory statement with respect to avoiding harmful drug interactions. The Division has prepared these statements as a single consumer alert, which may be downloaded from the Division's website at www.njconsumeraffairs.gov, in both English and in Spanish. On reproposal, new rule N.J.A.C. 13:45A-32.1(b) provides that a pharmacy shall conspicuously post an advisory statement prepared by the Division, notifying consumers about: (1) the availability of the pharmacy's drug price registry, including contact information for the Division; (2) their right to ask about price comparison information for generic prescription drugs; and (3) the need to tell the pharmacist and the consumer's healthcare practitioner about all medications and supplements the consumer is taking. This advisory statement must be posted at or adjacent to the prescription dispensing area, in the patient waiting area, or in any area where prescription drugs are delivered that is accessible by the general public, consistent with the requirements in N.J.S.A. 45:14-82. The Division believes that the placement of all three statements in a single notice in these areas will help to ensure that consumers will be aware of this relevant information prior to reaching the point of sale for their prescription drugs.

8. COMMENT: One commenter asked how the Division will make its compiled drug price list available to each pharmacy and whether the Division will provide printed copies to each pharmacy.

RESPONSE: The Division's list of the 150 most frequently prescribed drugs in the State, in their most commonly prescribed dosages, will be made available to all pharmacies through the Division's prescription drug price registry website. Pharmacies may download or print the list from the registry website.

9. COMMENT: One commenter suggested that proposed new rule N.J.A.C. 13:45A-30.1(a) be amended to provide pharmacies with the option of maintaining a drug price list that reflects the top 150 drugs dispensed from that particular pharmacy.

RESPONSE: The purpose of the New Jersey Prescription Drug Price Registry Act is to make retail price information for the 150 most frequently prescribed prescription drugs in the State readily available to consumers. The list that the Division has compiled, based on the data received from the Division of Medical Assistance and Health Services in the Department of Human Services, contains the 150 most frequently prescribed drugs in State. The Division cannot amend N.J.A.C. 13:45A-32.1(a) to allow a pharmacy to maintain a list that reflects the 150 most frequently prescribed drugs at that particular pharmacy because to do so would violate the express statutory requirements of N.J.S.A. 45:14-81.

10. COMMENT: One commenter objected to the requirement in proposed new rule N.J.A.C. 13:45A-30.1(e) that pharmacies post a sign notifying consumers of their ability to obtain price comparison information for generic prescription drugs. The commenter believes that this requirement exceeds the statutory authority conferred by the New Jersey Prescription Drug Price Registry Act. The commenter recommends that the requirement in subsection (e), that pharmacies post [page=1329] a sign advising consumers of their ability to obtain price comparison information for generic prescription drugs, as well as the requirement in subsection (b), that a pharmacy include on its prescription drug price list a statement advising consumers to ask about price comparison information for generic drug equivalents, be deleted. One commenter supports the inclusion of the generic drug price comparison information notice in the proposed new rule, noting that such information is essential in helping consumers realize cost savings on prescription drugs. The commenter recommends that the Division provide the actual language for the notice to all pharmacies in order to ensure consistency.

RESPONSE: The intent of the New Jersey Prescription Drug Price Registry Act and the goal of the registry are to allow consumers to readily obtain and compare the retail prices charged by pharmacies throughout the State for the 150 most frequently prescribed drugs, so that consumers may save money by finding the least expensive prescription drugs in their particular geographic area. The Division believes that providing consumers with pricing information with respect to generic drug equivalents, which may result in significant cost savings for consumers, is entirely consistent with the intent of the Act.

As originally proposed, N.J.A.C. 13:45A-30.1 required the posting of a notice, as well as a general statement on the pharmacy's drug price list, about generic drug equivalent pricing information. Reproposed new rule N.J.A.C. 13:45A-32.1 continues to require pharmacies to advise consumers about their right to see cost comparison information for generic drug equivalents by way of an advisory statement. As noted above, the Division has prepared a single advisory statement that must be posted by all pharmacies, which includes generic drug equivalent pricing information. Reproposed new rule N.J.A.C. 13:45A-32.1 does not require pharmacies to include the generic drug price information statement on the list itself. The Division believes that placement of this language on the list is not necessary in light of its inclusion on the Division-prepared sign.

11. COMMENT: One commenter inquired whether proposed new rule N.J.A.C. 13:45A-30.1(f), which permits a pharmacy to change the retail price for any drug on its prescription drug price list at any time, provided the list is updated at least weekly to reflect the new price, would require a pharmacy to update its list if no price changes occur.

RESPONSE: A pharmacy is not required to update its prescription drug price list if no price changes have occurred and the prices on the list reflect the pharmacy's current retail drug prices.

12. COMMENT: One commenter inquired how frequently the Division will update its list of the 150 most frequently prescribed drugs. One commenter inquired how the Division will correct the list to reflect brand to generic shifts and discontinued products. One commenter suggested that the Division update the list at least three to four times a year in order to ensure that the list contains pricing information for relevant prescription drugs.

RESPONSE: The Division will prepare the list of the 150 most frequently prescribed drugs in the State for distribution to pharmacies at least annually, as required by the New Jersey Prescription Drug Retail Price Registry Act at N.J.S.A. 45:14-82. The Division notes that it will work closely with the Division of Medical Assistance and Health Services in order to ensure that the prescription drugs contained on the Division's list are consistent with the 150 most frequently prescribed drugs in the State based on the data complied by the Division on Medical Assistance and Health Services.

13. COMMENT: One commenter expressed support for the advisory statement contained in proposed new rule N.J.A.C. 13:45A-30.1 encouraging consumers to make their pharmacist aware of other medications they are taking.

RESPONSE: The Division thanks the commenter for his support of this requirement.

14. COMMENT: One commenter recommended that the Division mandate a font size and typeface for a pharmacy's drug price list in order to ensure that the list is readable, especially for older consumers who may have difficulty reading small print.

RESPONSE: Reproposed new rule N.J.A.C. 13:45A-32.1 specifies that the pharmacy's drug price list shall be printed in at least 12-point type. The reproposed new rule does not mandate that a pharmacy's prescription drug price list be printed in a specific typeface. A pharmacy may utilize any typeface it chooses, provided that the typeface is readable.

15. COMMENT: One commenter recommended that proposed new rule N.J.A.C. 13:45A-30.1 require pharmacies to update their prescription drug price lists immediately upon a change in price.

RESPONSE: The New Jersey Prescription Drug Retail Price Registry Act, N.J.S.A. 45:14-82, permits a pharmacy to change the current retail price it charges for a drug at any time, provided the pharmacy updates its list at least weekly to reflect the new retail price. The Division, therefore, cannot amend reproposed new rule N.J.A.C. 13:45A-32.1 to require a pharmacy to immediately update the prices on its prescription drug price list.

The following is a summary of new rules N.J.A.C. 13:39-5.13 and 13:45A-32 that the Division and the Board of Pharmacy are jointly reproposing at this time.

The Division's reproposed new rule N.J.A.C. 13:45A-32.1 requires a pharmacy to maintain a price list with the names and retail prices of the drugs the pharmacy carries that are included on the Division's list of the 150 most frequently prescribed drugs. The price list must contain the retail price charged by the pharmacy for each listed drug's most commonly prescribed dosage, in quantities of 30, 60 or 90 units, if applicable, as well as the drug's price per unit. The pharmacy must post an advisory statement prepared by the Division notifying consumers about: (1) the availability of the pharmacy's drug price list; (2) their right to obtain price comparison information for generic prescription drugs; and (3) the need to tell the pharmacist and their healthcare practitioner about all medications the consumer may be taking in order to avoid harmful drug interactions. The sign must be posted at or adjacent to the prescription dispensing area, in the patient waiting area or in any area that is accessible by the general public where prescription drugs are delivered. The actual price list must be made available to consumers upon request and shall be printed in at least 12-point type.

A pharmacy may change the retail price it charges for any of the drugs on its price list at any time, provided the price list is updated at least weekly to reflect the new price. The date when the list was last updated by the pharmacy must be posted on the price list.

Finally, reproposed new rule N.J.A.C. 13:45A-32.1 provides that the Division will refer any pharmacy that fails to comply with the new rule to the Board of Pharmacy for appropriate disciplinary action.

Pursuant to reproposed new rule N.J.A.C. 13:39-5.13, a pharmacy must comply with all requirements imposed by the Division under new rule N.J.A.C. 13:45A-32.1. Reproposed new rule N.J.A.C. 13:39-5.13 also requires a pharmacy to comply with all requests for information from the Division concerning the pharmacy's prescription drug retail price list. Failure on the part of a pharmacy to comply with the requirements of the Division rule may result in the Board taking disciplinary action against the pharmacy permit holder and/or the pharmacist in charge.

The Division and the Board have provided a 60-day comment period for this notice of reproposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Division and the Board believe that reproposed new rules N.J.A.C. 13:39-5.13 and 13:45A-32.1 will have a positive impact upon consumers throughout the State by ensuring that, prior to purchase, they have access to the prices charged by their local pharmacies for the most frequently prescribed drugs in the State, in their most commonly prescribed dosage. The reproposed new rules will help to ensure that consumers are made aware of their right to obtain this information and to obtain drug cost comparison information for generic drug equivalents for prescribed brand name drugs. In addition, the notice required by the reproposed new rules concerning the need for consumers to advise their pharmacist and healthcare practitioner about all medications and supplements the consumer is taking may help consumers make more informed decisions regarding the filling of their prescriptions and avoid harmful drug interactions. The reproposed new rules may also positively impact pharmacy permit holders throughout the State to the extent that the rules will clarify for permit holders' their rights and responsibilities with respect to the provision of drug price comparison information to consumers.

[page=1330] Economic Impact

Reproposed new rules N.J.A.C. 13:39-5.13 and 13:45A-32.1 may have an economic impact upon pharmacies throughout the State to the extent that pharmacies may incur costs associated with maintaining drug price lists. The Division and the Board believe that any administrative costs incurred by pharmacies as a result of these requirements will be minimal and will be outweighed by the benefit to consumers in having retail drug price information available to them at the point of sale in their local pharmacies.

Federal Standards Statement

A Federal standards analysis is not required because the reproposed new rules are governed by N.J.S.A. 45:14-81. The reproposed new rules are not subject to any Federal requirements or standards.

Jobs Impact

The Division and the Board do not believe that the reproposed new rules will result in the creation or loss of jobs in the State.

Agriculture Industry Impact

The reproposed new rules will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

Currently, the Board of Pharmacy permits approximately 2,000 pharmacies. If pharmacy permit holders are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The reproposed new rules will not impose any reporting or recordkeeping requirements upon pharmacy permit holders. The reproposed new rules will, however, impose various compliance requirements upon permit holders. These compliance requirements are discussed in the Summary and Economic Impact statements above.

No additional professional services will be needed to comply with the reproposed new rules. The costs of compliance with the reproposed new rules are discussed in the Economic Impact statement above. The Division and the Board believe that the reproposed new rules should be uniformly applied to all pharmacy permit holders in order to ensure that prescription drug price information is available to consumers throughout the State. Therefore, no differing compliance requirements for any pharmacy permit holders are provided based upon the size of the business.

Smart Growth Impact

The Division and the Board do not believe that the reproposed new rules will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The reproposed new rules will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed rules concern the practice of pharmacy.

Smart Growth Development Impact

The reproposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the proposed rules concern the practice of pharmacy.

Full text of the reproposed new rules follows (additions indicated in boldface thus ):

CHAPTER 39

STATE BOARD OF PHARMACY

SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS

13:39-5.13 Prescription drug retail price list

(a) A pharmacy shall comply with all requirements imposed by, and all requests for information from, the Division of Consumer Affairs concerning prescription drug retail price lists as provided in N.J.A.C. 13:45A-32.1.

(b) Failure on the part of a pharmacy to comply with the requirements of N.J.A.C. 13:45A-32.1 may subject the permit holder and/or the pharmacist in charge to disciplinary action pursuant to N.J.S.A. 45:1-21 et seq.

(a) A pharmacy shall maintain a prescription drug retail price list containing the names of the 150 most frequently prescribed drugs in their most commonly prescribed dosage, made available to the pharmacy by the Director of the Division of Consumer Affairs pursuant to N.J.S.A. 45:14-82. The prescription drug retail price list shall contain the retail price charged by the pharmacy for each listed drug's most commonly prescribed dosage, in quantities of 30, 60 or 90 units, if applicable, and shall include the drug's price per unit. The date when the list was last updated by the pharmacy shall be noted on the list.

(b) A pharmacy shall conspicuously post an advisory statement prepared by the Division of Consumer Affairs and available for download on the Division's website at www.njconsumer affairs.gov , at or adjacent to the prescription dispensing area, in the patient waiting area or in any area where prescription drugs are delivered, which is accessible by the general public, notifying consumers about the following:

1. The availability of the pharmacy's prescription drug retail list, the consumer's right to ask for the current retail price that the pharmacy is charging for any drug on the price list and the availability of additional prescription drug price information from the Division of Consumer Affairs;

2. The right to obtain price comparison information for generic prescription drugs; and

3. The need to tell the pharmacist and the consumer's healthcare practitioner about all medications the consumer may be taking and to ask the pharmacist and the healthcare practitioner how to avoid harmful interactions between any drugs they may be taking.

(c) A pharmacy shall make a written prescription drug retail price list available to consumers for review upon request. The list shall be printed in at least 12-point type.

(d) A pharmacy may change the retail price for any of the drugs included on its prescription drug retail price list at any time, provided the prescription drug retail price list is updated as soon as possible, but at least weekly, to reflect the new retail price charged by the pharmacy.

(e) The Director of the Division of Consumer Affairs shall refer any pharmacy that fails to comply with this section to the Board of Pharmacy for appropriate disciplinary action.